Universal double offset surgical instrument

ABSTRACT

Instruments for use in anterior approach total hip arthroplasty. Instruments according to certain embodiments of the invention connect to a shaping member such as a broach, reamer or osteotome that is used to prepare the intramedullary canal of a desired femur or other bone for total hip arthroplasty. Such an instrument according to such embodiments can be configurable to allow operation on either the left or right leg, and in doing so to provide lateral offset and anterior offset of the instrument handle relative to the shaping member so that the patient&#39;s gut, musculature or other bodily portions may be avoided while still providing desired leverage and control over the shaping member to prepare the intramedullary canal.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/179,061, filed Feb. 12, 2014, now allowed, which is a divisional ofU.S. patent application Ser. No. 12/623,030, filed Nov. 20, 2009, nowU.S. Pat. No. 8,657,824, issued Feb. 25, 2014, which is acontinuation-in-part application of U.S. application Ser. No. 12/412,527filed Apr. 27, 2009, now U.S. Pat. No. 8,096,993, issued Jan. 17, 2012,which is a continuation application of U.S. application Ser. No.10/991,641 filed Nov. 18, 2004, now U.S. Pat. No. 7,591,821, issued Sep.22, 2009, which claims priority from U.S. Provisional Application Ser.No. 60/520,970, filed Nov. 18, 2003, all of which are incorporatedherein by this reference in their entirety.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

Not Applicable.

APPENDIX

Not Applicable.

BACKGROUND OF THE INVENTION

1. Field of the Invention

Embodiments of the invention relate generally to instruments for use inorthopedic surgery, and more particularly to instruments for use intotal hip arthroplasty.

2. Background of the Invention

Minimally invasive surgery techniques have become popular in total hiparthroplasty (THA) surgery. Advantages include minimizing soft tissuedamage, reducing recovery and healing time, and reducing the length ofstay in hospital. One version of such minimally invasive THA techniquesis the so-called “anterior approach” or “direct anterior approach” whichuses, for instance, a portal between the tensor fascia latae muscle andthe rectus femoris muscle. This approach can exploit the intervalbetween those muscles for both acetabular and femoral preparation, allowfor primary exposure of the hip joint capsule with minimization ofmuscle damage, limit incision length, and leverage other advantages.

Exposure of the proximal femoral intramedullary canal in order toprepare the canal to receive the femoral stem can be problematic in suchanterior approach THA's, however. Generally, the subject leg can bepositioned in extension, external rotation and adduction. The proximalfemur can be levered using wing retractors for further exposure of theintramedullary canal to access through the generally shorter thanconventional incision. Anatomical features of some patients, such as gutor muscle tissue, can nevertheless present problems in accessing andpreparing the femoral canal through the smaller incision. Moreparticularly, leverage of the proximal femur to correct orientationrelative to the incision and levering of an instrument directly throughthe incision to prepare the intramedullary canal can be obstructed bythe gut or musculature of some obese or muscular patients. Specialinstrument handles have been developed for such cases which includeanterior and lateral offsets. The bone shaping member, such as a broachor an osteotome, may be connected to the distal end of such a handle,inserted through the incision into the intramedullary canal of thefemur, and manipulated to avoid the gut or other musculature by virtueof the anterior and lateral offsets of the handle. See, e.g., M. Nogler,et al., A Double Offset Shaping Member Handle for Preparation of theFemoral Cavity in Minimally Invasive Direct Anterior Total HipArthroplasty, 21 J. Arthroplasty, pp. 1206-1208 (No. 8, 2006); U.S. Ser.No. 10/991,641 filed Nov. 18, 2004 entitled “Surgical Technique andInstrumentation for Minimal Incision Hip Arthroplasty Surgery;” and U.S.Ser. No. 12/412,527 filed Mar. 27, 2009 entitled “Surgical Technique andInstrumentation for Minimal Incision Hip Arthroplasty Surgery.” Allthree of these documents are incorporated herein by this reference.

Such instruments are physically large and heavy however, and separateinstruments are required for each of the right and left femurs in orderto provide the required lateral offset. Consequent issues include thoserelated to, among other things, logistics, inventory requirement, andexpense.

SUMMARY OF THE INVENTION

The present invention relates to instruments for THA and other similarsurgeries, which can be used in connection with surgery on the left orright body member, such as a femur.

There is provided:

In one embodiment, an instrument for shaping a medullary canal of both apatient's left leg and right leg, comprising: (a) a handle that includesa handle longitudinal axis; (b) a shaping member including: structureconfigured to shape bone; a shaping member longitudinal axis, and aconnecting structure that includes an interpositional cooperationstructure; (c) an offset member that physically connects the handle tothe shaping member, the offset member extending in an offset directionthat includes a first directional component in a first directionorthogonal to the longitudinal axis of the shaping member, and a seconddirectional component in the direction of the shaping memberlongitudinal axis; (d) the offset member including: (i) a first openingadapted to receive the shaping member connecting structure, the firstopening configured to receive the shaping member connecting structure ina manner whereby the shaping member longitudinal axis is substantiallyparallel to the handle longitudinal axis; (ii) a second opening adaptedto receive the shaping member connecting structure, the second openingconfigured to receive the shaping member connecting structure in amanner whereby the shaping member longitudinal axis is substantiallyparallel to the handle longitudinal axis; and (e) a retention device ormember comprising an actuator and at last one interpositional structure,the retention device or member configured to interpose the at least oneinterpositional structure relative to the interpositional cooperationstructure of the shaping member connecting structure when the actuatoris actuated.

In certain other embodiments, there is provided an instrument whereinthe shaping member comprises a reference plane and the first and secondopenings are configured to receive the shaping member connectingstructure in a manner such that the first direction orthogonal to thelongitudinal axis of the shaping member bisects the angle formed by theshaping member reference plane when the shaping member is connected tothe first opening and the shaping member reference plane when theshaping member is connected to the second opening.

In certain other embodiments, there is provided an instrument whereinthe shaping member comprises a reference plane and the first and secondopenings are configured to receive the shaping member connectingstructure in a manner such that when the shaping member is connected tothe first opening, the shaping member reference plane is substantiallyorthogonal to the shaping member reference plane when the shaping memberis connected to the second opening.

In certain other embodiments, there is provided an instrument whereinthe shaping member is a broach.

In certain other embodiments, there is provided an instrument whereinthe shaping member is a femoral shaping member for preparation of acentral femoral cavity for receiving a stem of a femoral component of aprosthetic hip.

In certain other embodiments, there is provided an instrument furthercomprising a strike plate with a first beveled surface that correspondsto the first opening on the offset member and a second beveled surfacethat corresponds to the second opening on the offset member.

In certain other embodiments, there is provided an instrument whereinthe offset member extends in at least two offset directions.

In certain other embodiments, there is provided an instrument whereinthe offset direction includes a third directional component that isorthogonal to the first directional component, the second directionalcomponent, and the longitudinal axis of the shaping member.

In certain other embodiments, there is provided an instrument whereinthe offset member includes a first abutment surface and a secondabutment surface, the first abutment surface corresponding to the firstopening and configured to abut a proximal surface of the shaping member,the second abutment surface corresponding to the second opening andconfigured to abut a proximal surface of the shaping member.

In certain other embodiments, there is provided an instrument whereinthe actuator of the retention device or member includes an over-centerlinkage configured to lock the interpositional structure in place wheninterposed with the interpositional cooperation structure of the shapingmember connecting structure, and wherein the interpositional structurecomprises at least one pawl.

In certain other embodiments, there is provided an instrument whereinthe actuator of the retention device or member includes a wedge, theinterpositional structure includes at least one claw, and the wedge isconfigured to urge the at least one claw into interposed position withthe interpositional cooperation structure of the shaping memberconnecting structure.

In yet another embodiment, there is provided an instrument for operatingon a medullary canal for installation of a prosthetic stem component ina patient, comprising: a handle including an elongated shaft extendingapproximately in a negative z-direction; a first offset capable ofextending in a first direction that includes an x-directional componentor a negative x-directional component; a second offset extending in asecond direction that includes a negative y-directional component; thehandle connected to either the first or second offset; an insertionmember extending from either the first offset or the second offset in aninsertion member direction that includes a negative z-directionalcomponent; wherein the negative y-directional component and negativez-directional components are orthogonal to each other and orthogonal tothe x-directional component and the negative x-directional component,and wherein the handle and the insertion member are positioned withrespect to one another in a non-planar relationship.

In another embodiment, there is provided an instrument wherein one ofthe offsets is connected to the handle via a pivot capable of rotatingrelative to the handle such that one of the offsets extends inapproximately an x-direction or a negative x-direction in order toconfigure the instrument for use with a right leg or a left leg of thepatient.

In another embodiment, there is provided an instrument wherein thehandle is configured to connect to the second offset on either a firstside of the handle that faces the x direction or a second side of thehandle that faces the negative x direction in order to form the firstoffset.

In another embodiment, there is provided an instrument wherein theinsertion member further comprises cutting elements.

In another embodiment, there is provided an instrument for operating ona medullary canal for installation of a prosthetic stem component in apatient, comprising: a handle including an elongated shaft extending inan approximately negative z-direction; an offset connected to thehandle, the offset extending in a first direction that includes anegative y-directional component and capable of extending in a seconddirection that includes an x-directional component or a negativex-directional component; a shaping member extending from the offset in ashaping member direction that includes a negative z-directionalcomponent, wherein the negative y-directional component and negativez-directional components are orthogonal to each other and orthogonal tothe x-directional component and the negative x-directional component,wherein the handle and the shaping member are positioned with respect toone another in a non-coplanar relationship, and wherein the shapingmember further comprises cutting elements.

In another embodiment, there is provided an instrument wherein theoffset is connected to the handle via a pivot, and the handle and pivotare capable of rotating relative to each other such that the offsetextends in a direction that includes an x-directional component or anegative x-directional component in order to configure the instrumentfor use with a right leg or a left leg of the patient.

In another embodiment, there is provided an instrument for operating ona medullary canal for installation of a prosthetic stem component in apatient, comprising: a handle member including a first section thatextends in a negative z-direction; a second section that extends in adirection having an x-directional component or a negative x-directionalcomponent and a negative y-directional component; and a third sectionthat extends in a direction that includes a negative z-directionalcomponent wherein the negative y-directional component and the negativez-directional components are orthogonal to each other and the negativey-directional component and the negative z-directional components areorthogonal to the x-directional component and the negative x-directionalcomponent; a strike plate configured to connect to the first section orthe third section of the handle member; and a shaping member configuredto connect to the first section or the third section of the handlemember; wherein when the strike plate is connected to the first sectionof the handle member and the shaping member is connected to the thirdsection of the handle member, the instrument is configured for operatingon a first leg of the patient, and when the strike plate is connected tothe third section of the handle member and the shaping member isconnected to the first section of the handle member, the instrument isconfigured for operating on a second leg of the patient.

In another embodiment, there is provided an instrument wherein theshaping member is a femoral shaping member.

In another embodiment, there is provided an instrument wherein theshaping member is a broach.

According to another embodiment, there is provided a method ofinstalling a prosthetic stem component into the medullary canal of aright leg or a left leg of a patient, comprising the steps of: obtainingan instrument capable of shaping a medullary canal of both a patient'sleft leg and right leg, comprising: (a) a handle that includes a handlelongitudinal axis; (b) a shaping member including: structure configuredto shape bone; a shaping member longitudinal axis, and a connectingstructure that includes an interpositional cooperation structure; (c) anoffset member that physically connects the handle to the shaping member,the offset member extending in an offset direction that includes a firstdirectional component in a first direction orthogonal to thelongitudinal axis of the shaping member, and a second directionalcomponent in the direction of the shaping member longitudinal axis; (d)the offset member including: (i) a first opening adapted to receive theshaping member connecting structure, the first opening configured toreceive the shaping member connecting structure in a manner whereby theshaping member longitudinal axis is substantially parallel to the handlelongitudinal axis; (ii) a second opening adapted to receive the shapingmember connecting structure, the second opening configured to receivethe shaping member connecting structure in a manner whereby the shapingmember longitudinal axis is substantially parallel to the handlelongitudinal axis; and (e) a retention device or member comprising anactuator and at last one interpositional structure, the retention deviceor member configured to interpose the at least one interpositionalstructure relative to the interpositional cooperation structure of theshaping member connecting structure when the actuator is actuated;selecting either the left leg or the right leg of the patient as the legfor installation of the prosthetic stem component; configuring theinstrument to operate on the selected leg by connecting the shapingmember to the first opening or the second opening; inserting theinstrument into the medullary canal of the selected leg through asurgical incision; operating on the medullary canal of the selected legwith the instrument; removing the instrument from the medullary canal ofthe selected leg; installing the prosthetic stem component in themedullary canal of the selected leg; and completing the surgery.

In another embodiment, there is provided a method of installing aprosthetic stem component comprising the step of obtaining an instrumentcapable of shaping a medullary canal of both a patient's left leg or aright leg includes obtaining an instrument that includes a strike plateconnected to the handle, the strike plate including a first beveledsurface that corresponds to the first opening on the offset member and asecond beveled surface that corresponds to the second opening on theoffset member; and the step of operating on the medullary canal of theselected leg with the instrument includes striking the instrument on apredetermined one of the first beveled surface and the second beveledsurface.

In another embodiment, there is provided a method of installing aprosthetic stem component into the medullary canal of a right leg or aleft leg of a patient, comprising the steps of: obtaining an instrumentcapable of operating on the medullary canal of the right leg or the leftleg of the patient for installation of a prosthetic stem component,comprising a handle including a shaft extending downward approximatelyin a negative z-direction, a first offset configured to extend from abottom of the elongated shaft in a first direction that includes anx-directional component or a negative x-directional component, a secondoffset extending from the first offset in a second direction thatincludes a negative y-directional component, and a shaping memberincluding structure configured to shape bone, the shaping memberextending downward from the second offset in a shaping member directionthat includes a negative z-directional component, wherein the negativey-directional component and the negative z-directional component areorthogonal to each other, and the negative y-directional component andthe negative z-directional component are orthogonal to the x-directionalcomponent and the negative x-directional component, and wherein thehandle and the shaping member are positioned with respect to one anotherin a non-planar relationship; selecting either the left leg or the rightleg of the patient as the leg for installation of the prosthetic stemcomponent; configuring the instrument to operate on the selected leg bycausing the first offset to extend from the handle in either thedirection that includes the x-directional component or the directionthat includes the negative-x directional component; inserting theinstrument into the medullary canal of the selected leg through asurgical incision; operating on the medullary canal of the selected legwith the instrument; removing the instrument from the medullary canal ofthe selected leg; installing the prosthetic stem component in themedullary canal of the selected leg; and completing the surgery.

In another embodiment, there is provided a method of installing aprosthetic stem component into the medullary canal of a right leg or aleft leg of a patient comprising the step of obtaining an instrumentcapable of operating on the medullary canal of the right leg or the leftleg of the patient includes obtaining an instrument that includes astrike plate connected to the handle, the strike plate including a firstbeveled surface that corresponds to the first opening on the offsetmember and a second beveled surface that corresponds to the secondopening on the offset member; and the step of operating on the medullarycanal of the selected leg with the instrument includes striking theinstrument on a predetermined one of the first beveled surface and thesecond beveled surface.

In another embodiment, there is provided a method of installing aprosthetic stem component into the medullary canal of a right leg or aleft leg of a patient wherein the step of inserting the instrument intothe medullary canal of the selected leg comprises inserting theinstrument into an anterior surgical incision.

In yet another embodiment, there is provided a method of installing aprosthetic stem component into the medullary canal of a right leg or aleft leg of a patient wherein the step of inserting the instrument intothe medullary canal of the selected leg comprises inserting theinstrument into a minimally invasive surgical incision.

In yet another embodiment, there is provided a method of installing aprosthetic stem component into the medullary canal of a right leg or aleft leg of a patient wherein the step of inserting the instrument intothe medullary canal of the selected leg comprises inserting theinstrument into a surgical incision that is from approximately 4 cm toapproximately 16 cm in length.

In yet another embodiment, there is provided a method of installing aprosthetic stem component into the medullary canal of a right leg or aleft leg of a patient wherein the step of inserting the instrument intothe medullary canal of the selected leg comprises inserting a femoralshaping member.

In yet another embodiment, there is provided a method of installing aprosthetic stem component into the medullary canal of a right leg or aleft leg of a patient wherein the step of inserting the instrument intothe medullary canal of the selected leg comprises inserting a broach.

In another embodiment, there is provided a method of installing aprosthetic stem component into the medullary canal of a right leg or aleft leg of a patient, comprising the steps of: obtaining an instrumentcapable of operating on the medullary canal of the right leg or the leftleg of the patient for installation of a prosthetic stem component, theinstrument comprising: a handle including an elongated shaft extendingapproximately in a negative z-direction; an offset connected to thehandle, the offset extending in a first direction that includes anegative y-directional component and capable of extending in a seconddirection that includes an x-directional component or a negativex-directional component; a shaping member extending downward the offsetin a shaping member direction that includes a negative z-directionalcomponent, wherein the negative y-directional component and negativez-directional components are orthogonal to each other and orthogonal tothe x-directional component and the negative x-directional component,wherein the handle and the shaping member are positioned with respect toone another in a non-planar relationship, and wherein the shaping memberfurther comprises cutting elements; selecting either the left leg or theright leg of the patient as the leg for installation of the prostheticstem component; configuring the instrument to operate on the selectedleg by causing the first offset to extend from the handle in either thedirection that includes the x-directional component or the directionthat includes the negative-x directional component; inserting theinstrument into the medullary canal of the selected leg through asurgical incision; operating on the medullary canal of the selected legwith the instrument; removing the instrument from the medullary canal ofthe selected leg; installing the prosthetic stem component in themedullary canal of the selected leg; and completing the surgery.

In another embodiment, there is provided a method of installing aprosthetic stem component into the medullary canal of a right leg or aleft leg of a patient wherein the step of obtaining an instrumentcapable of operating on the medullary canal of the right leg or the leftleg of the patient includes obtaining an instrument that includes astrike plate connected to the handle, the strike plate including a firstbeveled surface that corresponds to the first opening on the offsetmember and a second beveled surface that corresponds to the secondopening on the offset member; and the step of operating on the medullarycanal of the selected leg with the instrument includes striking theinstrument on a predetermined one of the first beveled surface and thesecond beveled surface.

In another embodiment, there is provided a method of installing aprosthetic stem component into the medullary canal of a right leg or aleft leg of a patient wherein the step of inserting the instrument intothe medullary canal of the selected leg comprises inserting a femoralshaping member.

In another embodiment, there is provided a method of installing aprosthetic stem component into the medullary canal of a right leg or aleft leg of a patient wherein the step of inserting the instrument intothe medullary canal of the selected leg comprises inserting a broach.

According to another embodiment, there is provided a method ofinstalling a prosthetic stem component into the medullary canal of aright leg or a left leg of a patient, comprising the steps of: obtainingan instrument capable of operating on a medullary canal for installationof a prosthetic stem component in a patient, comprising: a handle memberincluding a first section that extends in a negative z-direction; asecond section that extends in a direction having (i) an x-directionalcomponent or a negative x-directional component and (ii) a negativey-directional component; and a third section that extends in a directionthat includes a negative z-directional component wherein thex-directional component, the negative y-directional component and thenegative z-directional components are orthogonal to each other; a strikeplate configured to connect to the first section or the third section ofthe handle member; and a shaping member configured to connect to thefirst section or the third section of the handle member; wherein whenthe strike plate is connected to the first section of the handle memberand the shaping member is connected to the third section of the handlemember, the instrument is configured for operating on a first leg of thepatient, and when the strike plate is connected to the third section ofthe handle member and the shaping member is connected to the firstsection of the handle member, the instrument is configured for operatingon a second leg of the patient; selecting either the left leg or theright leg of the patient as the leg for installation of the prostheticstem component; configuring the instrument to operate on the selectedleg by connecting the shaping member to one of the first or thirdsection of the handle and connecting the strike plate to the other ofthe first or third section of the handle; inserting the instrument intothe medullary canal of the selected leg through a surgical incision;operating on the medullary canal of the selected leg with theinstrument; removing the instrument from the medullary canal of theselected leg; installing the prosthetic stem component in the medullarycanal of the selected leg; and completing the surgery.

In another embodiment, there is provided a method of installing aprosthetic stem component into the medullary canal of a right leg or aleft leg of a patient wherein the step of obtaining an instrumentcapable of operating on a medullary canal includes obtaining aninstrument wherein the strike plate includes a first beveled surfacethat corresponds to the left leg of the patient and a second beveledsurface that corresponds to the right leg of the patient; and the stepof operating on the medullary canal of the selected leg with theinstrument includes striking the instrument on a predetermined one ofthe first beveled surface and the second beveled surface.

In another embodiment, there is provided an instrument comprising aseparate adapter component that comprises the offset.

In another embodiment, there is provided an adapter capable of joining ahandle to a shaping member for shaping a medullary canal of a patient'sleg, the handle having a handle longitudinal axis and the shaping memberhaving a shaping member longitudinal axis, the adapter comprising: (a) abody; and (b) at least one post connected to the body and configured toconnect to the handle; and (c) a cavity that receives the insertionmember in a locking manner, wherein a longitudinal axis of the postrelative to a longitudinal axis of the cavity is oriented to connect theshaping member in a manner whereby the shaping member longitudinal axisis substantially parallel to the handle longitudinal axis; and whereinthe adapter extends in an offset direction that includes a firstdirectional component in a first direction orthogonal to thelongitudinal axis of the shaping member, and a second directionalcomponent in the direction of the shaping member longitudinal axis.

In another embodiment, there is provided an adapter wherein the adaptercomprises two posts, one of the posts being configured for shaping themedullary canal of a patient's right leg and the other of the postsbeing configured for shaping the medullary canal of a patient's leftleg.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and form a part ofthe specification, illustrate certain embodiments of the presentinvention and together with the description, serve to explain theprinciples of the invention. In the drawings:

FIG. 1 schematically shows portions of anatomy relevant to embodimentsof the present invention, including a left femur positioned relative toan acetabulum and pelvic cage; the drawing also includes reference axesand coordinate systems.

FIG. 2 shows the anatomy of FIG. 1 with the femoral head resected.

FIG. 3 shows the anatomy of FIG. 2 with the femur further externallyrotated for exposure of the intramedullary canal.

FIG. 4 shows the anatomy of FIG. 3 with the femur further adducted foradditional exposure of the intramedullary canal.

FIG. 5 shows the anatomy of FIG. 4, showing the femur further placed inextension for yet additional exposure of the intramedullary canal.

FIG. 6 shows a perspective view of an instrument according to a firstembodiment of the present invention assembled with an insertion memberin a first configuration for operating on the left femur.

FIG. 7 shows a perspective view of the instrument assembly of FIG. 6 ina second configuration for operating on the right femur.

FIG. 8 shows the instrument assembly of FIG. 6 positioned for operatingon the left femur.

FIG. 9 shows the instrument assembly of FIG. 7 positioned for operatingon the right femur.

FIG. 10 schematically shows a superior view of the instrument of FIG. 6positioned relative to a patient.

FIG. 11 shows a perspective view of the instrument assembly of FIG. 6positioned relative to the pelvic cage and left acetabulum.

FIG. 12 shows a perspective view of the instrument assembly of FIG. 7positioned relative to the pelvic cage and right acetabulum.

FIG. 13 shows the instrument assembly of FIG. 6 positioned relative tothe pelvic cage and left femur, in order to illustrate how the offsetsprovided by the instrument avoid interference from the gut zone whileaccessing the left femoral intramedullary canal.

FIG. 14 shows the instrument assembly of FIG. 7 positioned relative tothe pelvic cage and right femur, in order to illustrate how the offsetsprovided by the instrument avoid interference from the gut zone whileaccessing the right femoral intramedullary canal.

FIG. 15 shows a lateral perspective view of the instrument assembly ofFIG. 6 positioned relative to the left femur and the gut zone in asagittal plane.

FIG. 16 shows the instrument assembly of FIG. 7 positioned relative tothe pelvic cage and the right femur in order to demonstrate how leveragecan be applied to the bone shaping member of the instrument in order toprepare the intramedullary canal of the right femur without undueinterference by the gut zone.

FIG. 17 is a perspective view of an instrument according to someembodiments of the invention simultaneously showing a bone shapingmember superimposed on the instrument in two different configurations(for operating on a left and right femur).

FIG. 18 shows another perspective view of the instrument andsuperimposed bone shaping member configurations of FIG. 17.

FIG. 19 shows an elevated perspective view of the instrument andsuperimposed bone shaping member configurations of FIG. 17.

FIG. 20 shows a posterior perspective view of the instrument assembly ofFIG. 6.

FIG. 21 shows a medial perspective view of the instrument assembly ofFIG. 20.

FIG. 22 shows an elevated perspective view of the instrument assembly ofFIG. 20.

FIG. 23 shows a posterior perspective view of the instrument assembly ofFIG. 7.

FIG. 24 shows a medial perspective view of the instrument assembly ofFIG. 23.

FIG. 25 shows an elevated perspective view of the instrument assembly ofFIG. 23.

FIG. 26 shows a frontal view of the instrument shown in FIGS. 6-9 and11-25.

FIG. 27 shows a lateral perspective view of the instrument assembly ofFIG. 6 in order better to illustrate a locking linkage structurepositioned to lock the shaping member.

FIG. 28 shows another lateral perspective view of the instrumentassembly of FIG. 27.

FIG. 29 shows a medial perspective view of the instrument assembly ofFIG. 27 with the linkage positioned to unlock the bone shaping member.

FIG. 30 shows a close-up view of a distal portion of the instrumentassembly of FIG. 6, which better illustrates portions of the linkagemechanism.

FIG. 31 shows a close-up view of a distal portion of the instrumentassembly of FIG. 7, which better illustrates portions of the linkagemechanism.

FIG. 32 is a perspective view of the instrument of FIG. 20, which showscertain indicia.

FIG. 33A shows an interposition structure according to a first alternateembodiment according to the present invention.

FIG. 33B shows an interposition structure according to a secondalternate embodiment according to the present invention.

FIG. 34 shows a first alternate embodiment of an instrument according tothe present invention.

FIG. 35 shows a second alternate embodiment of an instrument accordingto the present invention.

FIG. 36A shows an alternative embodiment of a locking mechanismaccording to the present invention.

FIG. 36B shows a posterior perspective view of the instrument of FIG.36A.

FIG. 36C shows a dual offset handle of FIG. 36B with integral right andleft offsets.

FIG. 37 shows a locking mechanism according to another aspect of thepresent invention.

FIG. 38A shows a third alternate embodiment according to the presentinvention.

FIG. 38B shows a posterior perspective view of the instrument of FIG.38A, with the instrument positioned for operating on a right femur.

FIG. 38C shows a posterior perspective view of the instrument of FIG.38A, with the instrument positioned for operating on a left femur.

FIG. 39 shows a fourth alternate embodiment according to the presentinvention.

FIG. 40 shows a fifth alternate embodiment according to the presentinvention.

FIG. 41 shows a sixth alternate embodiment according to the presentinvention.

FIG. 42 shows a seventh alternate embodiment according to the presentinvention.

FIG. 43 shows an eighth alternate embodiment according to the presentinvention.

FIG. 44 shows a ninth alternate embodiment according to the presentinvention configured for operating on a left femur.

FIG. 45 shows portions of the embodiment of FIG. 44.

FIG. 46 shows a tenth alternate embodiment according to the presentinvention.

FIG. 47A shows a perspective view of an eleventh alternate embodimentaccording to the present invention configured for operating on a leftfemur.

FIG. 47B shows a posterior perspective view of the instrument of FIG.47A.

FIG. 47C shows an elevated perspective view of the instrument of FIG.47A.

FIG. 47D shows an exploded view of the instrument of FIG. 47B from aposterior perspective.

FIG. 47E is a medial perspective view of the instrument of FIG. 47D,illustrating how an offset component may be rotated for use with a rightfemur.

FIG. 47F shows an alternate lateral exploded view of the instrument ofFIG. 47E after the offset component has been rotated for operating on aright femur.

FIG. 47G shows an elevated view of the assembled instrument of FIG. 47F,before the strike plate is rotated for use with a right femur.

FIG. 47H shows another elevated view of the assembled instrument of FIG.47G, after the strike plate is positioned for operating on the rightfemur.

FIG. 47I shows an exploded view of the instrument of FIG. 47H from alateral perspective.

FIG. 47J shows the instrument of FIG. 47I as assembled.

FIG. 47K shows a posterior perspective view of the instrument of FIG.47J.

FIG. 47L is a posterior perspective view of the instrument of FIG. 47J.

FIG. 47M shows an elevated perspective view of the instrument of FIG.47L.

FIG. 48A shows a side view of another version of a shaping member.

FIG. 48B shows a frontal view of the shaping member of FIG. 48A.

FIG. 48C shows a twelfth embodiment of an instrument assembly accordingto the present invention, the instrument including the shaping member ofFIG. 48A positioned for operating on the right femur.

FIG. 48D shows a posterior perspective view of the instrument assemblyof FIG. 48C.

FIG. 48E shows another perspective view of the instrument assembly ofFIG. 48C, the instrument assembly including the shaping member of FIG.48A positioned for operating on the left femur.

FIG. 48F shows a posterior perspective view of the instrument assemblyof FIG. 48E.

FIG. 49A shows an exploded view of a thirteenth embodiment of aninstrument according to the present invention, with a shaping memberpositioned for operating on the left femur.

FIG. 49B shows a partial exploded view of the instrument of FIG. 49A,with a shaping member positioned for operating on the right femur.

FIG. 49C shows an alternate view of FIG. 49B.

FIG. 50A shows a side view of another version of a shaping member.

FIG. 50B shows a frontal plane view of the shaping member of FIG. 50A.

FIG. 50C shows a fourteenth embodiment of an instrument according to thepresent invention, the instrument including the shaping member of FIG.50A and positioned for operating on the left femur.

FIG. 50D shows a posterior perspective view of the instrument of FIG.50C.

FIG. 50E shows an elevated view of the instrument of FIG. 50C.

FIG. 50F shows an exploded view of the instrument of FIG. 50C from aposterior perspective.

FIG. 50G shows a medial perspective view of the instrument of FIG. 50F,showing how the offset component may be rotated for operating on a rightfemur.

FIG. 50H shows an alternate view of the instrument of FIG. 50G after theoffset component has been rotated for use with a right femur.

FIG. 50I shows an elevated perspective view of the instrument of FIG.50H before the strike plate is rotated for use with a right femur.

FIG. 50J shows another elevated perspective view of the instrument ofFIG. 50I after the strike plate is rotated for operating on a rightfemur.

FIG. 50K shows an exploded view of the instrument of FIG. 50J from alateral perspective.

FIG. 50L shows a lateral perspective view of the assembled instrument ofFIG. 50K.

FIG. 50M shows another perspective view of the instrument of FIG. 50L,which is configured for operating on a right femur.

FIG. 50N shows another posterior view of the instrument of FIG. 50Fassembled together.

FIG. 50O shows an elevated view of the instrument of FIGS. 50J-M.

FIG. 51A-1 shows a perspective view of another version of a shapingmember according to the present invention.

FIG. 51A-2 shows a top view of the shaping member of FIG. 51A-1.

FIGS. 51B and 51C show distal ends of an instrument according to otherembodiments of the present invention.

FIG. 51D shows a cross-sectional view of the shaping member of FIG. 51A.

FIG. 52A-1 shows a perspective view of another version of a shapingmember according to the present invention.

FIG. 52A-2 shows a top view of the shaping member of FIG. 52A-1.

FIG. 52B shows the distal end of an instrument according to anotherembodiment of the present invention.

FIGS. 52C and 52D show cross-sectional views of the shaping member ofFIG. 52A positioned for operating on left and right femurs,respectively.

FIG. 53A shows the distal portion of an instrument according to anotherembodiment of the present invention.

FIG. 53B shows a shaping member according to another embodiment of thepresent invention positioned for operating on left femur.

FIG. 53C shows a shaping member of FIG. 53B after it has been rotated180 degrees for operating on right femur.

FIG. 54A shows an instrument assembly according to a fifteenthembodiment of the present invention configured for operating on a leftfemur.

FIG. 54B shows a superior view of the assembly shown in FIG. 54A in use.

FIG. 55A shows an instrument assembly according to a sixteenthembodiment of the present invention configured for operating on a rightfemur.

FIG. 55B shows a superior view of the assembly shown in FIG. 55A in use.

FIGS. 56A and 56B show a locking mechanism for a shaping memberaccording to some embodiments.

FIGS. 57A-D show an adapter according to one embodiment of the presentinvention.

FIG. 57E shows the adapter of FIG. 57A connected to a handle andconfigured for operating on a right femur.

FIG. 57F shows the assembly of FIG. 57E, alternatively configured foruse on a left femur.

FIG. 57G is a top view of the assembly shown in FIG. 57E, configured foruse on a right femur.

FIG. 58A shows an adapter according to another embodiment of the presentinvention configured for operating on a right femur.

FIGS. 58B-C show various view of the adapter of FIG. 58A connected to ahandle and a shaping member.

FIG. 59A shows an adapter according to yet another embodiment of thepresent invention configured for operating on a left femur.

FIG. 59B shows the adapter of FIG. 59A connected to a handle and ashaping member.

DETAILED DESCRIPTION OF THE EMBODIMENTS

FIGS. 1-5 are provided for context. FIG. 1 shows sawbones correspondingto human bone anatomy from a frontal aspect in the context of coronalplane 10, transverse plane 12, and sagittal plane 14. Coronal plane 10,transverse plane 12, and sagittal plane 14 are conventional surgicalreference planes and are oriented orthogonally to one another. In thecontext of THA anterior approach surgery, the patient, whose anatomyincludes pelvic cage 16 and femur 18, is positioned on an operatingtable face up. Accordingly, FIG. 1 shows the pelvic cage 16 and thefemur 18 from an anterior or coronal plane 10 aspect. Femur 18 includesfemoral head 20 which is received in hip cup or acetabulum 22.

Corresponding to coronal plane 10, transverse plane 12 and sagittalplane 14, are reference axes X, Y and Z also shown in FIG. 1 and labeled24, 26 and 28 respectively. Axis 24 includes an X direction and anegative X direction. For purposes of this document, the X direction ofaxis 24 always corresponds to the patient's lateral side, while thenegative X direction of axis 24 always corresponds to the patient'smedial side. Thus, the X direction and negative X direction aredifferent from the idea of patient left and patient right. Axis 26includes a Y direction and a negative Y direction which correspond tothe anterior and posterior directions respectively. Axis 28 includes a Zdirection and a negative Z direction, which correspond to the superiorand inferior directions respectively. For purposes of this document,axes X, Y and Z (24, 26, and 28) can be used to define directions whichinclude components along one or more of the axes.

The coordinate system that includes coronal plane 10, transverse plane12, and sagittal plane 14 generally corresponds to the orientation ofthe patient's anatomy. For purposes of this document, it can alsocorrespond to the X, Y and Z coordinate system using axes 24, 26 and 28as shown in FIG. 1, except that the X direction and negative X directionalways refer to the patient's lateral and medial directions,respectively, where “lateral” corresponds to a direction toward theoutside of the patient's body and “medial” corresponds to a directiontoward the inside of the patient's body. Thus, on both the left andright side of a patient's body, the X direction is lateral, and on boththe left and right side of a patient's body the negative X direction ismedial. See, for example, FIG. 10.

The coordinate system that includes axes 24, 26 and 28 can also exist atany orientation in space independent of coronal plane 10, transverseplane 12, and sagittal plane 14 of a particular patient, such as thepatient whose anatomy is shown in FIG. 1. It is sometimes useful, suchas in certain instances discussed later in this document, to considerthe structure of a particular instrument in the context of thecoordinate system that includes axes 24, 26 and 28, even where thatinstrument and that coordinate system have been removed from theimmediate vicinity of a particular patient or his or her coronal plane10, transverse plane 12 and sagittal plane 14. Accordingly, thecoordinate system that includes axes 24, 26 and 28 should be consideredas convenient for defining directions of particular structuralcomponents of instruments according to certain embodiments of theinvention relative to each other, although not absolutely in terms of aparticular direction such as magnetic north, a radius of the earth, or ameridian of longitude. As an example, some drawings in this documentshow instruments in the context of reference axes: The page that bearsthe drawing showing the instrument and coordinate system that includes24, 26 and 28 can be translated and rotated in space in at least 6degrees of freedom, and the image of the instrument and the coordinatesystem will similarly translate and rotate but nevertheless continue toshow location and orientation of components of the instrument relativeto each other regardless of how the translation or rotation of the pageor the instrument may vary.

Nevertheless, as shown in FIG. 1, it is sometimes useful to consider theinstrument as it is aligned relative to the patient, and thus theCartesian coordinate system that includes axes 24, 26 and 28 with thesurgical reference system that includes the frontal, sagittal andcoronal planes. In that case, the Z direction of axis 28 corresponds tothe superior direction, while the negative Z direction of axis 28corresponds to the inferior direction relative to the patient's anatomy.Similarly, the Y direction of axis 26 corresponds to the anteriordirection, while the negative Y direction corresponds to the posteriordirection. Moreover, for purposes of this document, the X direction ofaxis 24 corresponds to a lateral direction of the patient, while thenegative X direction of axis 24 corresponds to a medial direction of thepatient, as shown in FIG. 1.

FIG. 2 shows the femur 18 of FIG. 1 after resection. FIGS. 3 and 4 showthe femur 18 externally rotated and adducted, respectively, to exposethe intramedullary canal 30 that will ultimately receive the femoralcomponent of a femoral implant of a total hip prosthesis. FIGS. 3 and 4are for illustrative purposes only and show an intramedullary canal 30that has been at least partly shaped. These figures accordingly do notnecessarily precisely reflect what the proximal portion of theintramedullary canal 30 and femur 18 will look like after resection,rotation and adduction.

FIG. 5 is a sagittal view that shows the externally rotated and adductedfemur 18 also placed in extension to further expose the intramedullarycanal 30 for preparation using an instrument according to an embodimentof the invention. Intramedullary canal preparation is generallynecessary in order ultimately to receive a femoral component. It shouldbe noted that only some hospitals have surgical tables that enable suchextension of the femur. The instruments disclosed herein are especiallyuseful in instances where the extension step shown in FIG. 5 is notpossible due to equipment limitations.

FIGS. 6 and 7 show an instrument 40 according to a first embodiment ofthe present invention that can be used to prepare the intramedullarycanal of either or both a left or right femur for total hip replacementor other hip surgery. Instrument 40 shown in FIGS. 6 and 7 connects to,and can be considered to include when assembled, a shaping member 42.FIGS. 6 and 7 show the shaping member 42 in the form of a broach but anyshaping member such as a reamer, osteotome, sawblade, graft impactionmember, broach or other device configured to prepare the intramedullarycanal of a bone can be used as a shaping member 42. It should be notedthat instead of a shaping member 42, instrument 40 may be advantageouslyconfigured to allow insertion of an intramedullary implant such as afemoral stem, for instance, through the use of an adaptor or otherwise.Instrument 40 may be formed of any desired material with appropriatestrength, manufacturability, autoclavability, cost, and other desiredperformance factors. A preferred embodiment is formed of surgical gradestainless steel, but other metal and/or plastic materials may be used,and combinations of materials may be used.

Instrument 40 shown in FIGS. 6 and 7 generally also includes a handle 44whose proximal portion is connected to a strike plate 46 and whosedistal portion is connected to an offset 48 which in turn connects tothe shaping member 42.

Handle 44 of the particular instrument 40 shown in FIGS. 6 and 7 is astraight elongated structure with a tubular cross section and alongitudinal axis 54 aligned with the length of handle 44. Across-section of handle 44 can be tubular, rectangular shaped, or anyother desired shape and hollow, partially hollow, solid or as otherwisedesired. Primarily, handle 44 serves to provide the surgeon structure togrip and manipulate instrument 40 during surgery while allowing thesurgeon also to impact strike plate 46 or an end of instrument 40 withappropriate striking structures such as hammers or other devices. Inother embodiments which are not shown, the handle 44 and the offset 48may be blended together to form an arc to reduce material use andprovide better clearance from a patient's gut zone, musculature and/orother body portions.

Strike plate 46 of instrument 40, which is optional, can be a structureof any desired shape and configuration formed at or connected to aproximal portion of handle 44. For example, while not shown in thedrawings, strike plate 46 may alternately be configured as an integralslap hammer. Among other things, strike plate 46 can enlarge the surfaceon which the surgeon strikes instrument 40 with a striking device suchas a hammer or mallet to operate on bone. Strike plate 46 can alsoprovide striking surfaces that are offset from the longitudinal axis ofthe handle 44 in order to enhance transmission of force from impact ofthe striking device on instrument 40 to the shaping member 42 as itinteracts with the bone. Additionally, strike plate 46 can include oneor more beveled surfaces 56A and 56B. Strike surface 56A serves as theleft hip strike plate surface and 56B serves as the right hip strikeplate surface. These surfaces 56A and 56B allow instrument 40 to bestruck in a direction more closely aligned with the direction in whichforce needs to be transmitted for optimal effect on bone of the shapingmember 42. In the version shown in FIGS. 6 and 7, the strike plate 46 isgenerally square in cross-section with a left bevel and a right bevelwhich correspond to the position of the shaping member 42 when it isconnected to instrument 40 for operating on a left femur 18 or rightfemur 52 respectively.

Offset 48 in the particular instrument 40 shown in FIGS. 6 and 7constitutes a member that extends from the distal portion of handle 44in a direction that is angled from the direction in which handle 44extends. The particular offset 48 shown in FIGS. 6 and 7 is a straightelongated structure with a tubular cross section and a longitudinal axis58 aligned with the length of offset 48. A cross-section of offset 48can be tubular, rectangular shaped, or any other desired shape andhollow, partially hollow, solid or as otherwise desired. The orientationof offset 48 is selected to cause handle 44 to be offset from shapingmember 42 laterally and anteriorly with respect to the patient, whetherinstrument 40 is being used in connection with a left leg or a rightleg. The nature and extent of such lateral and anterior offsets can bechosen as desired, but generally allow instrument 40 to providesufficient control and leverage over shaping member 42 in order to shapethe intramedullary canal of the femur efficiently and effectively, whileavoiding the gut zone, musculature and/or other body portions ofpatients such as obese or highly muscled individuals. Instrument 40 mayalso allow clearance from other instrumentation placed on a patient,such as an array for use with a computer assisted surgery (CAS) systemplaced in the pelvic region. The length of offset 48, and its shape,angulation and other structural features can be selected as desired toprovide the desired lateral and anterior offset. In the particularinstrument 40 shown in FIGS. 6 and 7, offset 48 and its axis 58 areoriented at approximately 45 degrees to handle 44 and its axis 54. Asnoted above, in other embodiments which are not shown, the handle 44 andthe offset 48 may be blended together to form an arc to reduce materialuse and provide better clearance from a patient's gut zone, musculatureand/or other body portions.

The orientation of instrument 40 shown in FIG. 6 combined with itsconnection to shaping member 42 configures instrument 40 for preparationof an intramedullary canal of a left femur. Note that the offset 48extends from shaping member 42 in a direction that includes lateral(x-axis) and anterior (y-axis) components to cause the handle 44 to bedisposed generally parallel to, but offset laterally and anteriorly,from shaping member 42. In FIG. 7, the same instrument accepts shapingmember 42 in another configuration to cause the handle 44 to be alignedgenerally parallel to shaping member 42 but offset laterally andanteriorly for purposes of preparing the intramedullary canal of a rightfemur. The shaping member 42 used for the right femur can be the samedevice as used for the left femur, or different devices can be used foreach of the right and left femurs. For example, there can be a speciallyprepared shaping member 42 that corresponds to the right femur, and aspecially prepared shaping member 42 that corresponds to the left femur.

FIG. 8 shows the instrument 40 as configured in FIG. 6 positioned toinsert shaping member 42 into the intramedullary canal of the left femur18. The offset 48 which offsets handle 40 laterally and anteriorly tothe shaping member 42 can be seen to allow the handle 44 to avoid thegut zone of the patient when the instrument 40 is positioned andoriented for an anterior approach.

FIG. 9 shows the instrument 40 as configured in FIG. 7 with the shapingmember 42 inserted in the intramedullary canal 50 of right femur 52. Theinstrument 40 is the same device shown in FIG. 8, but the shaping member42 has been connected to instrument 40 in a different way to allow theright femur 52 to be accommodated rather than the left femur 18. Onceagain, instrument 40 allows preparation of the intramedullary canal 50with the benefit of the lateral and anterior offset of handle 44relative to shaping member 42 provided by offset 48.

FIG. 10 is a schematic from a superior perspective that shows theanterior and lateral offset of a handle 44 relative to a shaping member42 of an instrument 40, which can be accomplished using variousstructures in various ways according to various aspects of the inventionso that the instrument 40 can accommodate either a left femur 18 orright femur 52.

FIGS. 11 and 12 are perspective views of the pelvic cage 16 and theinstrument 40 showing instrument 40 positioned in FIG. 11 to prepare theintramedullary canal of the left femur 18 and in FIG. 12 to prepare theintramedullary canal of the right femur 52. FIGS. 11 and 12 provideadditional visual perception of how the offset of handle 44 relative toshaping member 42 provided by the particular structure of instrument 40allows handle 44 to avoid the gut zone of the patient whether instrument40 is configured for preparation of the intramedullary canal of the leftfemur 18 or the right femur 52.

FIGS. 11 and 12 are useful to characterize, among other things, aspectsof the structure and geometry of the instrument 40 shown in thosefigures as well as broader aspects of the structure and geometry ofinstruments according to certain embodiments of the invention moregenerally. Instrument 40 shown in FIG. 11 is the same instrument asinstrument 40 shown in FIG. 12, but in FIG. 11 it is configured foroperation on the left femur 18 while in FIG. 12 it is configured foroperation on the right femur 52.

In FIG. 11, instrument 40 includes a handle 44 which is aligned with Zaxis 28 and extends distally in the negative Z direction. Since theinstrument 40 is generally aligned with the patient's anatomy in thatillustration, the handle 44 also extends distally in the inferiordirection of the patient's anatomy. If, however, the instrument 40 isremoved from the vicinity of the patient, or reoriented substantially,handle 44 would in any event for purposes of this document extenddistally in the negative Z direction since the X, Y, Z coordinate systemcorresponds to the instrument 40 independent of how the instrument 40 isaligned relative to the patient in the frontal, sagittal and coronalplanes. Connected to a distal portion of handle 44 is an offset 48,which extends from handle 44 toward shaping member 42 in a directionthat contains a negative X directional component and a negative ydirectional component. Since the instrument 40 as shown in FIG. 11 isgenerally aligned with the patient's anatomy and is configured foroperation on the left femur 18, the offset 48 also extends in adirection that includes a medial component and a posterior directionalcomponent relative to the patient's anatomy; again, if the instrument 40is removed from the vicinity of the patient, or reorientedsubstantially, the offset 48 would in any event for purposes of thisdocument extend in a direction that contains a negative X directionalcomponent and a negative y directional component, regardless of the factthat those components no longer correspond to the medial and posteriordirections of the patient's anatomy. It should be noted that the ratioof lateral to anterior offset of the handle 44 (or handle axis 54) withrespect to the shaping member 42 (or shaping member axis 68) may varybetween greater than zero and infinity, however, it is preferred thatsaid ratio lies within the range of 0.5-1.5, and more preferably, about1.

In FIG. 12, as in FIG. 11, the handle 44 is aligned with Z axis 28 andextends distally in the negative Z direction. Since the instrument 40 isgenerally aligned with the patient's anatomy in that illustration, thehandle 44 also extends distally in the inferior direction of thepatient's anatomy. Again, however, if the instrument 40 is removed fromthe vicinity of the patient, or reoriented substantially, handle 44would in any event for purposes of this document extend distally in thenegative Z direction since the X, Y, Z coordinate system corresponds tothe instrument 40 independent of how the instrument 40 is alignedrelative to the patient in the frontal, sagittal and coronal planes ofthe patient's anatomy. Unlike FIG. 11, however, FIG. 12 shows theinstrument 40 configured to operate on the right femur 52. Accordingly,connected to a distal portion of handle 44 is offset 48, which extendsfrom handle 44 toward shaping member 42 in a direction that contains anegative X directional component and a negative Y directional component.Since the instrument 40 as shown in FIG. 12 is generally aligned withthe patient's anatomy and is configured for operation on the right femur52, the offset 48 also extends in a direction that includes a medialcomponent and a posterior directional component relative to thepatient's anatomy; again, if the instrument 40 is removed from thevicinity of the patient, or reoriented substantially, offset would inany event for purposes of this document extend in a direction thatcontains a negative X directional component and a negative Y directionalcomponent, regardless of the fact that those components no longercorrespond to the medial and posterior directions of the patient'sanatomy. Among other things, the direction in which offset 48 extendsfrom handle 44 in FIG. 12 includes a negative X directional componentthat corresponds to the patient's medial direction. Similarly, thedirection in which offset 48 extends from handle 44 in FIG. 11 includesa negative X directional component that corresponds to the patient'smedial direction. In the particular instrument 40 shown in FIGS. 11 and12, the change of direction in which offset 48 extends from handle 44 isaccomplished by connecting shaping member 42 to offset 48 in a differentlocation on offset 48 and at a different orientation relative to offset48 in FIG. 11 as compared to FIG. 12, and also rotating handle 44 sothat the offset 48 extends, in both cases, medially and posteriorly fromthe handle 44 (laterally and anteriorly from the shaping member 42) whenthe instrument 40 is generally aligned with the patient's anatomy tooperate on either the left femur 18 or right femur 52.

FIGS. 13 and 14 are views similar to FIGS. 11 and 12, but with thefemurs 18 and 52 themselves in the field of view to show more clearlyhow positioning and orientation of the shaping member 42 corresponds tothe intramedullary canal 30 of left femur 18 (FIG. 13) or theintramedullary canal 50 of right femur 52 (FIG. 14).

FIG. 15 is a sagittal view of instrument 40 positioned for preparationof the intramedullary canal 30 of left femur 18. This figure providesadditional visual perspective on how the offset of handle 44 relative toshaping member 42 helps avoid the gut zone of the patient. In thatsense, offset 48 offsets handle 44 from shaping member 42, or viceversa.

FIG. 16 is a generally transverse superior perspective view thatprovides additional visual perspective on how the offset of handle 44relative to shaping member 42 of instrument 40 helps avoid the gut zonewhen instrument 40 is configured for preparing the intramedullary canalof a right femur 52.

As disclosed in this document, the invention includes multiplestructures and embodiments for achieving the lateral and anterior offsetof handle 44 relative to shaping member 42 (medial and posterior offsetof shaping member 42 relative to handle 44) in a single instrument 40that can accommodate the intramedullary canal of both a left femur and aright femur. Instrument 40 as shown in FIGS. 6-9 and 11-16, for example,includes a single structural offset 48 which extends from handle 44along a generally linear longitudinal axis that is oriented in adirection that contains a negative Y directional component and anegative X directional component when configured for the left or theright leg, in order to provide the lateral and anterior offset of handle44 from shaping member 42. However, the invention contemplates anystructure which connects a handle 44 and a shaping member 42 where theinstrument 40 can be configured to provide a lateral and anterior offsetof the handle relative to the shaping member for each of the left femur18 and right femur 52 in order to prepare the intramedullary canal 30 ofa left femur 18 or a right femur 52. Such structures can include, forinstance, any physical structure that provides lateral and anteriordirectional components or offsets from shaping member 42 to handle 44and/or strike plate surface or surfaces 56, or conversely, medial andposterior offsets or directional components when proceeding from handle44 and/or strike plate surface or surfaces 56 to shaping member 42.

Instrument 40 is more clearly shown in FIGS. 17-26. In the instrument 40shown in FIGS. 17-26, offset 48 includes or connects to a handleconnecting structure 60, located at the distal portion of offset 48.Handle connecting structure 60 generally includes an opening or otherstructure for receiving or accommodating connecting structure of ashaping member 42, in addition to a structure accommodating linkage thatis configured to lock or retain shaping member 42 in place. While notshown, the handle connecting structure 60 may be separable from offset48, or may comprise separate adapters or elements to accommodate varioustypes of shaping members 42.

In the instrument 40 of the embodiment shown in FIGS. 17-26, instrumentconnection structure 60 includes a pair of shaping member receptionopenings 62 and space 64 for accommodating a retention linkage 66.Reception openings 62 are configured in shape and dimension tocorrespond to connection structures such as projections on shapingmembers 42, in order to hold and orient such structures to position andorient shaping members 42 relative to offset 48 and handle 44appropriately. In that vein, openings 62 are oriented in a directionthat generally aligns the longitudinal axis 68 of shaping member 42 tobe generally parallel with the longitudinal axis 54 of handle 44. Insome embodiments, only a single opening 62 may be provided at a distalportion of offset 48, in which the longitudinal axis 68 of shapingmember 42 is not generally aligned to be parallel with the longitudinalaxis 54 of handle 44. The longitudinal axis 68 of shaping member 42 isgenerally the axis that extends through shaping member 42 in a directionthat corresponds to the direction of the intramedullary canal inpatients for whom the shaping member 42 is intended. Reception openings62 and/or linkage accommodation space 64 also allow linkage 66 to besituated relative to offset 48 so that the linkage 66 can be actuated inorder to interpose an interposition structure 70 such as a pawl, claw orother structure into an interposition cooperation structure or retainingrecess 72 on shaping member 42 in order to retain shaping member 42 inposition and proper orientation relative to instrument 40. Receptionopenings 62 are perhaps best seen in FIGS. 21, 24 and 26 from anexterior aspect and FIGS. 19, 22 and 25 from a superior aspect. Linkageaccommodation 64 can be seen in all of these figures. Interpositionstructure cooperation structure or retaining recess 72 on shaping member42 is perhaps best seen in FIGS. 19, 22, and 25. There, shaping member42 is shown to have a post 74 connection structure with an interpositionstructure cooperation structure 72. In some embodiments, a free endportion of the post 74 may have one or more second interpositioncooperation structures (e.g., a transversely extending slot) forengaging one or more second interposition structures (e.g., atransversely extending pin) located within the instrument 40, in orderto facilitate the orientation of the shaping member 42 relative to theinstrument 40, and to allow orienting of the shaping member 42 relativeto the instrument 40 to be performed independently of a locking functionprovided by the interposition and interposition cooperation structures.The post 74 is received in a reception opening 62 of instrument 40, andthe retaining recess 72, here a notch, is situated on post 74 of shapingmember 42 to cause shaping member 42 to be oriented so that referenceplane 76, such as a plane of symmetry, of shaping member 42 is generallyaligned in a direction such that as the longitudinal axis 68 of shapingmember 42 is aligned with the longitudinal axis 54 of the handle 44, thereference plane 76 of the shaping member 42 can be considered to definea direction from which offset 48 provides appropriate lateral andanterior offset to the handle 44 from the longitudinal axis 68 ofshaping member 42. As can be seen in FIGS. 19, 22 and 25, the referenceplane 76 of shaping member 42 is, in the instrument 40 of the embodimentshown in those figures, generally aligned with the strike direction 78of beveled surfaces 56 of strike plate 46. As shown in FIGS. 19, 22 and25, position and orientation of openings 62 are preferably symmetricalin the superior aspect about longitudinal axis 58 of offset 48. In thataspect, each opening 62 is angulated from that axis 58 at approximately45 degrees, although other angulation magnitudes and/or directions canbe employed, depending on a number of factors including offset of handle44 from shaping member 42, angulation and position of strike plate 46and its beveled surfaces 56, or if no strike plate is used, structureand configuration of a proximal end or other appropriate structure onhandle 44.

FIGS. 20-22 show instrument 40 configured for surgery on a left femur18, while FIGS. 23-25 show instrument 40 configured for surgery on aright femur 52. FIG. 20 shows instrument 40 oriented so that referenceplane 76, such as a plane of symmetry of shaping member 42 is orthogonalto the printed page. That axis thus appears as a line on FIG. 20. FIG.20 thus shows instrument 20 as would be seen from a posterior aspect ofa patient whose left femur is being operated on. In that sense, offset48 proceeds laterally from shaping member 42 and anteriorly, or “intothe page” from shaping member 42 to form the offset magnitude anddirection from which the handle 44 is offset from the shaping member 42.Thus, offset 48 as shown in FIG. 20 proceeds from shaping member 42 in adirection that includes an X directional component or lateraldirectional component, and a positive Y directional component oranterior directional component, to form the offset of longitudinal axis54 of handle 44 (or of handle 44 itself) relative to the longitudinalaxis 68 of shaping member 42 (or to shaping member 42). Offset 48 alsoincludes a Z or superior directional component as it extends fromshaping member 42 to handle 44, so that ultimately the direction oflongitudinal axis 58 of offset 48 shown in FIG. 20 is a resultant orfunction of these X, Y, Z directional components.

FIG. 21 shows the instrument 40 configured for surgery on the left femur18 in the sagittal plane from a medial aspect. There, offset 48 can beseen to be extend from shaping member 42 to handle 44 in a directionthat includes a lateral or X directional component, an anterior or Ydirectional component, and a superior or Z directional component to formthe offset between shaping member 42 and handle 44; the magnitude anddirection of these directional components create the resultant thatcorresponds to the direction of the offset geometry 82 of the handle 44longitudinal axis 54, or the handle 44 itself, relative to the shapingmember 42 longitudinal axis 68, or to the shaping member 42 itself. Inthe transverse plane as shown in FIG. 22, offset geometry 82 can be seento be a function of the positive X or lateral directional component 84and the Y or anterior directional component 86.

FIGS. 23-25 show instrument 40 configured for operation on a right femur52 using the same shaping member 42 as shown in FIGS. 20-22, but withthe shaping member 42 inserted in the other reception opening 62 ofinstrument 40 that corresponds to the right femur 52. FIG. 23 showsinstrument 40 in a coronal plane, from a posterior aspect. Accordingly,offset 48 proceeds laterally and anteriorly from shaping member 42 tohandle 44. Thus, when instrument 40 has been configured to shape a rightfemur 52 intramedullary canal, the offset from the shaping member 42longitudinal axis 68 to handle 44 longitudinal axis 54 as seen in atransverse plane (FIG. 25) is formed by the magnitude and direction ofthe positive X or lateral directional component 84 and the anterior orpositive Y directional component 86.

FIG. 24 is a sagittal view of the instrument 40 configured for shapingthe right femur 52 intramedullary canal, from a medial aspect. ComparingFIG. 22, which shows instrument 40 in a transverse plane configured forsurgery on a left femur 18 to FIG. 25, which shows the instrument 40 ina transverse plane configured for surgery on the right femur 52, theorientation of offset structure 48, shaping member 42, and offsetgeometry 82 can be seen to be a mirror image about longitudinal axis 58of offset structure 48 when instrument 40 is configured for surgery onthe left femur 18 as opposed to when it is configured for surgery on theright femur 52. In FIGS. 22 and 25, the angulation between referenceplane 76 of shaping member 42 when instrument 40 is configured forsurgery on the left femur 18 is 90 degrees from the orientation ofreference plane 76 of shaping member 42 when the instrument 40 isconfigured for surgery on the right femur 52. However, suchperpendicularity is not required; rather, the divergence angle 88 thatreference plane 76 of shaping member 42 forms relative to longitudinalaxis 58 of offset 48 is a function of, among other things, the structureof shaping member 42, the position and orientation of connectingstructure 74 of shaping member 42, the position and orientation ofopenings 62, the structure, positioning and orientation of offset 48,and the desired distance and directional relationships betweenlongitudinal axis 68 of shaping member 42 and longitudinal axis 54 ofhandle 44 to form offset geometry 82. As in the case of instrument 40shown in FIGS. 6 and 7, offset 48 could be modular, adjustable, curved,contain multiple segments, some or all of which are not parallel to eachother, or be shaped in any manner desired, with any desired crosssection, to create directional components 84 and 86 in order to form theoffset geometry 82.

Considerations to be taken into account in that respect includematerials, desired geometry, amount of offset needed for clearance ofthe gut zone, manufacturability, cost, and particular reamers, broaches,osteotomes, impaction grafting devices, or other shaping members 42,with which instrument 40 will be used.

FIG. 26 shows a frontal view of instrument 40 without shaping members 42for better illustration of instrument connection structure 60 thatincludes reception openings 62 and linkage accommodation 64.

FIGS. 27-32 show instrument 40 of the first embodiment (see FIGS. 6-9and 11-16) with linkage 66 for retaining shaping member 42 in instrument40. The primary difference in the structure of instrument 40 shown inthese figures from the instrument 40 shown in FIGS. 17-26 is the linkageaccommodation structure 64 and other structure for accommodating linkage66. The instrument 40 of FIGS. 6-9 and 11-16 includes a slot 90 in thehandle, and the linkage accommodation 64 is a larger cavity than ininstrument 40 of the second embodiment as shown in FIGS. 17-26. The slot90 of the particular structure shown in FIGS. 27-32 extends through thehandle 44 to receive in pivoting relationship an actuator lever 92 whichcan be rotated toward the handle 44 to engage interposition structure 70of linkage 66 relative to interposition cooperation structure 72 onposts or other structures 74 of shaping member 42. A link 94, which maybe configured as a leaf spring, connects the distal end of lever 92 tointerposition structure 70 in the form of a claw, pawl or similarphysical interference structure which is mounted in linkageaccommodation 64 to pivot relative to offset 48. When actuator lever 92is rotated away from handle 44, link 94 is pulled proximately (Zdirection) and releases a spring force to pivot interposition structure70 and thus withdraw it from the position in which it would beinterposed in interposition structure cooperation structure 72 of theshaping member 42. When lever 92 is rotated into position against handle44, the connection 98 and geometry of lever 92 distal end relative tolink 94 rotates that connection 98 beyond top dead center of thelever-to-handle connection 100 (defined here relative tolink-to-interposition structure connection 102) so that force oninterposition structure 70 tending to disengage interposition structure70 from shaping member 42 tends to urge actuator lever 92 against handle44. Such structure is known as an “over center configuration.” Otherself-locking structures could be used such as, among others, caromingmechanisms, worm/thread mechanisms, rack and pinion mechanisms,ratcheting devices, sliding collars, latching devices, or alternativelyno self-locking or self-retaining structure is required for holdinginterposition structure 70 in place relative to interposition structurecooperation structure 70 to shaping member 42. Other mechanisms may beused as interposition structures 70, such as, for instance, set screws,wedges, pins, or other mechanical means that can be interposed relativeto instrument 40 and shaping member 42 to hold shaping member 42 inplace relative to instrument 40. If linkage 66 is used, it need notextend to handle 44, for example, the linkage may be contained on onlyoffset portion 48.

FIGS. 30 and 31 show the link 94, the interposition structure 70 in theform of claws or pawls 96, and the link-to-interposition structureconnection 102 and how they can be positioned relative to linkageaccommodation 64 according to some embodiments. FIGS. 30 and 31 makeclear that, in this particular structure shown in these figures, a leftclaw or pawl 96 corresponds to the opening 62 into which shaping member42 fits for surgery on a left femur 18, while a right claw or pawl 96operates similarly to constraining shaping member 42 for surgery on theright femur 52. Various structures and linkages may be used. FIG. 32shows an alternate perspective view of the spatial relationships betweenthe strike plate 56 and the shaping member 42 when configured foroperating on a left femur.

FIG. 33A shows a schematic of another instrument 40 locking mechanismthat features another type of interposition structure 70. There, a wedge104 is urged distally by rotation of a wedge nut 106 provided as agraspable externally rotatable sleeve on the offset 48 to bear againstand urge, in turn, locking claws 108 about pivots 110 into place ininterposition structure cooperation structure 72 of shaping member 42. Ameans for biasing said claws 108 together such as a return spring asshown may be provided. The return spring may be of any type includingcompression springs, torsional springs, or leaf springs. As shown inFIG. 33B, the claws 108 may themselves be provided with said means forbiasing, for instance, designed with integral leaf springs. Insertionmembers 42 described herein may be provided with ambidextrous connectingportions as shown in FIG. 33B.

Instruments according to other embodiments of the present invention cancreate an anterior and lateral handle-to-shaping-member offset toachieve the universal left leg-right leg aspect of the invention byusing, among other things, pivoting structure, repositionable structure,transpositionable structure or, as is the case in some respects withrespect to the first two embodiments discussed above, an instrumentwhich is multiconfigurable to accommodate both legs. Such instrumentscan have one offset which extends between shaping member 42 and handle44 in a direction that has lateral, anterior and superior directionalcomponents for each desired femur 18, 52, or the shaping member 42 maybe offset from handle 44 using structure that may include one or moresections or portions, one, some or all of which may include multipleshapes and extend in different directions. Examples are discussed below,with the understanding that the invention comprehends any instrumentthat is configurable to accommodate surgery on the intramedullary canalof both the left femur 18 and right femur 52 including a handle and/or astrike plate portion and a shaping member and containing structure thatcreates an offset of the handle and/or strike plate portion bothlaterally and anteriorly from the shaping member, for each of the leftfemur 18 and right femur 52, while the handle and/or strike plateportion and shaping member remain generally parallel or aligned foreffective force transmission to the shaping member from the handle orstrike plate portion. Note that embodiments with a single distal opening62 may not allow the shaping member 42 axis to be generally parallelwith the handle.

FIG. 34 shows an instrument 140 according to a first alternateembodiment of the invention that uses a pivoting structure to achievethe left-right universality aspect of the invention. Handle 144 isconnected to a first offset 148(a) which extends generally orthogonallyfrom handle 144. Second offset 148(b) is pivotally connected to firstoffset 148(a) to extend either way from first offset 148(a) to causefirst 148(a) to extend along the negative Y axis, in order to allowinstrument 140 to accommodate either the left femur 18 or right femur 52respectively. Shaping member 142 is shown in FIG. 34 integral to secondoffset 148(b), though it may be connected to offset 148(b) via anydesired instrument connection structure 160. A strike plate 146 maycontain bevels (not shown) which can be similar to beveled surfaces 56of instrument 140 of the first embodiment to improve the direction offorce transmission to the shaping member 142.

FIG. 35 shows an instrument 240 according to a second alternateembodiment of the invention that uses a repositionable structure toaccomplish offset of handle 244 relative to shaping member 242. Handle244 extends in a distal or negative Z direction and can be attached toan offset 248 on either side of the handle 244. The connection to theside of the handle 244 is the structure that creates an offset in the Xdirection in order to create the lateral offset, while offset 248extends in the posterior or negative Y direction to create the lateraland anterior offset of handle 244 relative to shaping member 242. Theoffset 248 can be connected to handle 244 using screws, clevis pins,tongue and groove structure, mating key ways or slides, spring and latchmechanisms, detents or any other desired structure. Again, any desiredinterconnection structure 260 can be used, if one is needed, to connectshaping member 242 to offset 248.

FIGS. 36A and 36B a modular instrument 340 according to some embodimentsof the invention that use repositionable structure to achieve an offsetin accordance with the invention. There, handle 344 receives an offset348 that is connectable at either end to handle 344 and at either end toshaping member 342. The offset 348 extends from the handle 344 in adirection that includes a negative Y or posterior directional componentand an X directional component. When the offset 348 is manipulated sothat its other end is connected to handle 344, the offset in the Xdirection is changed to accommodate the contra-lateral hip. Forinstance, if a first end of offset 348 is connected to handle 344 andthe offset extends in the direction that contains a negative Ydirectional component and an X directional component to accommodate aleft femur, its other, second end can be connected to handle 344 on anopposing side of the handle 344 axis, so that it extends from handle 344in a direction that accommodates the other femur. Offset 348 can bestraight, curved, doglegged, or any other desired shape. It can beconnected to handle 344 and shaping member 348 via any desired structureincluding screws, clevis pins, tongue and grooves, mating key ways orslides, spring and latch mechanisms, detents or as otherwise desired. Insome embodiments, as shown in FIG. 36C, two offsets 348 may beintegrally provided on handle 344 in order to create a Y-shapedinstrument. During use, only one offset 348(a) is used and provides alateral and anterior offset, while the other offset 348(b) provided foruse with the contra-lateral hip extends away from the surgical site andfloats in space.

As shown in FIG. 37, an ambidextrous cam and follower arrangement 347may be provided on either one of or both of the handle 344 and offset348 to secure the offset 348 to the handle 344. A rotatable lever 356may be provided on a pivot structure 360 in order to facilitate movementbetween the cam and follower arrangement 347 by way of mechanicaladvantage, thereby creating a frictional lock between the handle 344 andthe offset member.

FIGS. 38A-38C show an instrument 440 according to a third embodiment ofthe invention. There, a handle 444 is slideably connected to a firstoffset 448(a) which in turn connects to a second offset 448(b). Thesliding engagement between the handle 444 and first offset 448(a) may befacilitated by a track 450 having means 468 for fixing the handle 444 tothe first offset 448(a), such as a set screw or spring-loaded latchingbutton. The first offset 448(a) and second offset 448(b) help align thelongitudinal axis 468 of shaping member 442 to be essentially parallelwith longitudinal axis 454 of handle 444. First offset 448(a) slidesrelative to handle 444 in order to provide the lateral offset desiredfor left or right femur. Either or both first offset 448(a) or secondoffset 448(b) can extend in a direction that includes the posterior ornegative Y component in order to provide the desired anterior offset ofhandle 444 relative to shaping member 442. Second offset 448(b) may beprovided with adjustment means, such as an adjustable track means 460(best shown in FIG. 38A) in order to vary the amount of anterior offset.In other words, an offset in the Y-axis between the handle 444 andshaping member 442 may be varied and set by securing the second offset448(b) to the first offset 448(a) via securing means 443. Moreover,while shaping member 442 and second offset 448(b) are shown to beintegral in FIGS. 38A-C, it will be appreciated that second offset448(b) may be provided with an interposition structure 470 configured toaccept and to secure thereto, one or more separable shaping members. Anydesired locking mechanism 468, 460 may be used to lock the slideablefirst offset 448(a) and second offset 448(b) into place, and any desiredinterposition structure can be used, as disclosed in this document orotherwise, and as is the case with all embodiments disclosed in thisdocument, to retain shaping member 442 in position relative toinstrument 440.

FIG. 39 shows an instrument 540 according to a fourth embodiment of thepresent invention. There, handle 544 is connected in pivoting fashion toan offset 548 that pivots or swivels relative to the longitudinal axis554 of handle 544. Offset 548 extends in a direction that includes an Xdirectional component and a negative Y or posterior directionalcomponent. When the offset 548, handle 544, and shaping member 542 areswiveled to a first position, it provides desired lateral and anterioroffset of handle 544 relative to shaping member 542 to accommodate afirst leg. When the offset 548, handle 544, and shaping member 542 arepivoted and locked in the other position, it provides desired lateraland anterior offset to accommodate the other leg. Again, the pivotingconnection between handle 544 and offset 548 can be constructed asdesired with suitable locking mechanism, and the shaping member 542 canbe connected to offset 548 with interconnection structure 560 asdesired.

FIG. 40 shows an instrument 640 according to a fifth embodiment of thepresent invention. There, handle 644 having a handle axis 654 isconnected to an offset 648 that extends from handle 644 to shapingmember 642 in a direction or directions that include or includes anegative Y or posterior component. Offset 648 may comprise one or moreoffset portions 648 a, 648 b. Attached distally thereto is a link which,depending upon the direction on which said link is pivoted relative tohandle 644 and offset 648, provides an X directional component toprovide the desired lateral offset of handle 644 relative to shapingmember 642 for either a left or a right femur. In this version, thepivoting of the link occurs relative to handle 644 about the Y/negativeY axis to provide the left-right universality aspect of the invention.The shaping member 642 can be connected on either side of the distal endof the offset 648 so that it extends in a distal or negative Z directionfrom offset 648. It is preferred that the shaping member axis 668remains generally parallel to the handle axis 654 in both left and righthip configurations. Any desired interconnection structure can be used toconnect shaping member 642 to offset 648.

FIG. 41 shows an instrument 740 according to a sixth embodiment of theinvention. There, handle 744 is connected in pivoting fashion to anoffset 748 that pivots or swivels relative to the longitudinal axis 754of handle 744. Offset 748 extends in a direction that may include anegative Z or distal directional component, a negative Y or posteriordirectional component, and an X directional component. When the offset748 is swiveled to a first position, it provides desired lateral andanterior offset of handle 744 relative to shaping member 742 toaccommodate a first leg. When pivoted and locked in the other position,it provides desired lateral and anterior offset to accommodate the otherleg. Again, the pivoting connection between handle 744 and offset 748can be constructed as desired with suitable locking mechanism, and theshaping member 744 can be connected to offset 748 with anyinterconnection structure as desired.

FIG. 42 shows an instrument 840 according to a seventh embodiment of theinvention, which is similar in some respects to the embodiment shown inFIG. 39. There, handle 844 is pivotally connected to an offset 848 thatextends from handle 844 to the shaping member in both a negative X (ormedial) direction, and a negative Y (or posterior) direction in order toprovide lateral and anterior offsets to the handle 844 relative to theshaping member 842. In this version, the pivoting of the handle 844occurs relative to offset 848 about the Y/negative Y axis to provideuniversality. The shaping member 842 can be connected on either side ofthe distal end of the offset 848 so that it extends in a distal ornegative Z direction with respect to the handle 844 position. Anydesired interconnection structure 860 can be used to connect anddisconnect shaping member 842 to offset 848; here, a release lever onthe offset is shown.

FIGS. 43-45 show an instrument 940 according to another version ofpivotable embodiments according to the present invention. There, handle944 is connected to a first offset 948(a) that extends from handle 944in a negative X or medial direction. The second offset 948(b) ispivotally connected to the first offset 948(a) to extend in the negativeY direction to provide anterior offset of handle 944 relative to shapingmember 942. The pivot structure that connects first offset 948(a) tosecond offset 948(b) can be constructed as desired with lockingstructure to lock second offset 948(b) in place to provide the desiredlateral offset. As shown more closely in FIG. 45, second offset 948(b)can connect to shaping member 942 using interconnection structure 960 inthe form of a swivel, if desired in order to accommodate left and rightsurgical sites. Any other interconnection structure 960 can be used toallow shaping member 942 to be connected to the distal end of secondoffset 948(b) for operation on a first leg in a first position and foroperation on the other leg 180 degrees away from that position. As shownin FIG. 43, first and second offsets 948(a) and 948(b) may be combinedinto a single length of material that provides both posterior andlateral offset of the handle 944 relative to the shaping member 942 whenoffset 948(a),(b) is swiveled to accommodate the right or left leg.

FIG. 46 shows an instrument 1040 according to another version ofmulticonfigurable instruments according to the present invention. There,instrument 1040 includes a member 1041 that serves functions of handle1044 and offset or offsets 1048. The member 1041 includes an “A” end1056 and a “B” end 1058. When a first leg is the subject of surgery, oneof the A and B ends can connect to shaping member 1042 and the other ofsaid A and B ends can connect to a strike plate 1046. When the other legis the subject of surgery, the member 1041 can be rotated about theX-axis so that the other end connects to shaping member 1042. The endthat does not connect to the shaping member 1042 connects to, ifdesired, a strike plate 1046. The end of member 1041 that connects tothe strike plate 1046 can be considered as handle 1044 that proceedsdistally in a negative Z direction. It then transitions to an offsetportion 1048 that proceeds in a negative Y (or posterior) direction and,a negative X (or medial) direction, then to transition back to anegative Z direction.

FIG. 47A-M show a modular instrument 1140 according to another versionof multiconfigurable instruments according to the present invention. Inthis embodiment, instrument 1040 includes a strike plate 1146, handle1144, offset 1148, and shaping member 1142. As shown in FIGS. 47D-F,instrument 1140 is modular with respect to strike plate 1146 and handle1144, with respect to handle 1144 and offset 1148, and with respect tooffset 1148 and shaping member 1142. Offset 1148 includes an “A” end anda “B” end, 1156 and 1158 respectively. When a first leg is the subjectof surgery, one of the A and B ends of offset 1148 connects to shapingmember 1142 and the other of the A and B ends of offset 1148 connects tohandle 1144. FIGS. 47A-E show various views of an instrument configuredto operate on a left femur. When the other leg is the subject ofsurgery, offset 1148 is rotated 180 degrees about the X axis, as shownin FIGS. 47D-F, so that the other end of offset member 1148 connects toshaping member 1142 and the opposite end connects to handle 1144. Toaccommodate the other leg, the strike plate 1146 is also rotated asshown in FIGS. 47G and 47H. FIGS. 47F and 47H-M show various views ofthe instrument 1140 configured to operate on the right femur.

The strike plate 1146 may contain beveled surfaces 1156, which can besimilar to an accomplished function of beveled surfaces 56 of instrument140 of the first embodiment.

FIGS. 48A-F show an instrument assembly 1240 that is conceptuallysimilar in some ways to instrument 40 described above, in that itprovides both anterior and lateral offsets to the handle axis relativeto a shaping member axis. However, the instrument assembly 1240 shown inFIGS. 48A-F utilizes two connection structures such as two correspondingposts 1274, 1276 on the shaping member 1242, and only one correspondingconnection structure such as a receiving recess on a distal portion ofthe instrument 1240. The connection structures 1274, 1276 provided onthe shaping member 1242 may be angled with respect to the shaping memberaxis and handle axis so as to effectively provide an anterior andlateral offset of the handle 1244 relative to the shaping member 1274when assembled and positioned for use on a patient. As shown in FIGS.48A-F, the shaping members 1242 provide an anterior and lateral offsetof the handle 1244 relative to the shaping member 1274 when used withsymmetrical handles 1244 having a single offset 1248.

Instrument assembly 1240 includes a handle 1244 and a shaping member1242 having two posts 1274 and 1276 adapted to interface with offset1248 to connect shaping member 1242 to the distal end of offset 1248. Asshown in FIGS. 48C-D, post 1276 of shaping member 1242 connects to thedistal end of offset 1248 for operation on the right femur. As shown inFIGS. 48E-F, post 1274 of shaping member 1242 attaches to the distal endof offset 1248 instead of post 1276 for operation on the left femur. Inthe embodiment shown in FIGS. 48A-F, offset 1248 comprises only a singleoffset with respect to the handle 1244.

FIGS. 49A-C show an instrument 1340 having handle 1344,optionally-chamfered strike plate 1346, offset 1348, and shaping member1342. Shaping member 1342 includes a protrusion 1374 configured to bereceived within either a first receiving geometry or a second receivinggeometry, 1290 and 1292 respectively, in the distal end of offset 1348,depending on whether the instrument is used to operate on the right orthe left femur. As shown in FIG. 49A, the instrument 1340 is positionedso that protrusion 1374 of shaping member 1342 is aligned with the firstreceiving geometry 1290 of the distal end of offset 1348 for operationon the left femur. FIGS. 49B-C show the positioning of instrument 1340for operation on the right femur, so that the protrusion 1374 of theshaping member 1342 is aligned with the second receiving geometry 1292of the distal end of offset 1348. Any desired structure can be used toretain the shaping member 1342 in the respective desired receivinggeometry 1290, 1292.

FIG. 50A-0 shows a modular instrument 1440 according to another versionof multiconfigurable instruments according to the present invention. Inthis embodiment, instrument 1440 includes a strike plate 1446, handle1444, offset 1448, and shaping member 1442. Shaping member 1442 includesa post 1472 that is angled to be received within a corresponding opening1441 in the distal end of offset 1448. As shown in FIGS. 50E-H,instrument 1440 is modular with respect to strike plate 1446 and handle1444, with respect to handle 1444 and offset 1448, and with respect tooffset 1448 and shaping member 1442. Offset 1448 includes an “A” end anda “B” end, 1456 and 1458 respectively, as shown in FIGS. 49F-H. When afirst femur is the subject of surgery, one of the A and B ends of offset1448 connects to shaping member 1442 and the other of the A and B endsof offset 1448 connects to handle 1444. FIGS. 50C-G show views of aninstrument configured to operate on a left femur. When the right femuris the subject of surgery, offset 1448 is rotated 180 degrees about theX-axis, as shown in FIGS. 50G-H so that the other end of offset member1448 connects to shaping member 1442 and the opposite end connects tohandle 1444. To accommodate the other femur, the strike plate 1446 isalso rotated around the Z-axis as shown in FIGS. 50I and 50J. FIGS.50J-O show various views of the instrument 1440 configured to operate onthe right femur.

The strike plate 1446 may contain beveled surfaces 1456, which can besimilar to an accomplished function of beveled surfaces 56 of instrument40 of the first embodiment.

FIGS. 51A-D show another mechanism for connecting a shaping member 1542having an opening 1550 to posts 1574 of distal end of an offset member1548, such as one described above. As shown in FIG. 51A-2, opening 1550can have any suitable cross section, including but not limited tocircular, oval, triangular, or rectangular. Post 1574 includes aprojection 1572 that can be received within a locking recess 1548 of theshaping member 1542 (shown in FIG. 51D). When post 1574 is inserted intoopening 1550, springs 1520 in the offset member 1548 cause projection1572 to pivot about pivot 1560 until the projection 1572 is capturedwithin recess 1548 to retain the shaping member 1542 to the offsetmember 1548.

FIGS. 52A-D show another mechanism for connecting a shaping instrument1642 having two openings 1650 and 1652 to a post 1674 of distal end ofan offset member 1648 such as one described above. Openings 1650 and1652 can have any suitable cross section, including but not limited tocircular, oval, triangular, or rectangular as shown in FIG. 52A-2. Post1674 includes a projection 1672 that can be received within eitherlocking recess 1646 or 1648, depending on which opening post 1674 isreceived within (shown in FIG. 52 C-D). When post 1674 is inserted intoone of the openings 1650 or 1652, a spring 1620 causes projection 1672to pivot until projection 1674 is received within the appropriate recess1646 or 1648. Spring 1620 may be provided as compression spring (asshown), a torsion spring, tension spring, or a leaf spring separate orintegrally formed with any of the above.

FIG. 53A shows a distal portion of a handle 1744 having a protrusion1750. FIGS. 53B-C show a shaping member 1742 having a recess 1754configured to receive protrusion 1750 of handle 1744 via a taper-lockingconnection such as a Morse taper. Recess 1754 and protrusion may haveany suitable configuration, such as frustoconical or tapered with anoval cross-section. The instrumentation shown in FIGS. 53A-C isparticularly useful if modular necks are used in conjunction with theshaping member in situ during trial reduction. Recess 1754 may besymmetrical as shown in FIGS. 53B-C, and the shaping member 1742 may beinserted into either a right or left femur and be able to receivemodular trial necks for trialing a left or right implant. Moreover, ifrecess 1754 is symmetrical as shown in FIGS. 53B-C, then the position ofthe shaping member 1742 with respect to the handle 1744 may be rotated180 degrees to accommodate left and right hips. Means for breaking ataper connection between the handle 1744 and the shaping member 1742 mayalso be provided (not shown). Such means may be, for instance, aspring-loaded plunger that creates an impact force to the taperconnection. Moreover, means for removing the shaping member 1742 fromthe surgical site (e.g., intramedullary canal) may be provided to theoffset 1744. Such means may be, for example, provided by a screw 1750(b)located on the handle 1744 which engages a thread hole 1754(b) in theshaping member 1742.

FIG. 54A shows an instrument assembly 1840 according to a fifteenthembodiment of the present invention configured for operating on a leftfemur. FIG. 54B shows a superior view of the assembly shown in FIG. 54Ain use relative to a patient's left hip. It can be seen from FIG. 54Bthat the handle 1844 may comprise a linkage mechanism to secure aninsertion member 1842 to a distal end of an offset 1848. The assembly1840 provides both a lateral offset and anterior offset of the strikeplate 1846 surface relative to the insertion member 1842. A normal tothe strike plate 1846 surface used is generally parallel to the axis ofthe insertion member 1842. Shown in FIG. 54B, the axis 1868 of theinsertion member 1842 and the normal to the “Left” surface of the strikeplate 1846 are generally parallel to the Z-axis. However, in thisembodiment, both the handle axis 1854 and offset 1848 are not generallyparallel with the axis 1868 of the insertion member 1842.

FIG. 55A shows an instrument assembly 1940 according to a sixteenthembodiment of the present invention configured for operating on a rightfemur. The instrument assembly 1940 shows an alternative embodiment of astrike plate 1946 having a V-shaped profile. FIG. 55B shows a superiorview of the assembly shown in FIG. 55A in use. It can be seen from FIG.55B that the handle 1944 may comprise a linkage mechanism to secure aninsertion member 1942 to a distal end of an offset 1948. The assembly1940 provides both a lateral offset and anterior offset of the strikeplate 1946 relative to the insertion member 1942. A normal to the“Right” strike plate 1946 surface used is generally parallel to the axis1968 of the insertion member 1942 and to the Z-axis. However, as withthe embodiment shown in FIGS. 54A and 54B, the handle axis 1954 and theaxis 1958 of the offset 1948 are generally not parallel with the axis1968 of the insertion member 1942.

FIGS. 56A and 56B show a locking mechanism for an insertion memberaccording to some embodiments. In the embodiment shown, an ambidextrousfork-shaped yoke slides transversely across a receiving portionconfigured to receive a post portion of an insertion member (e.g., abroach post). A moveable linkage controls the transverse movement of theyoke to either lock or unlock the insertion member to the handle.Locking may be facilitated by a separate leaf spring or a link which isdesigned with an integral leaf spring. Yoke fingers may be prismatic andhave a cross-section that is generally triangular in order to complimentthe notches typically provided on conventional insertion member postportions.

FIGS. 57A-57G illustrate an adapter 1810 that provides a dual offsetwhen assembled with a conventional single offset handle and conventionalinsertion member 1442 (e.g., broach) used for operating on a patient'smedullary canal. In some embodiments, the adapter 1810 includes a body1812 and a recess 2002 for receiving post 1472 of insertion member 1442.In other embodiments, the adapter 2000 has a protrusion for insertioninto a cavity of a conventional post-less insertion member (not shown).

As shown in FIG. 57D, the adapter 1810 in some embodiments includes twoposts 2072 and 2074 that are configured to connect with a receivingportion of a conventional handle used for operating on a patient'smedullary canal. Post 2072 connects to the handle when operating on theright femur, and post 2074 connects to the handle when operating on theleft femur.

In use, as shown in FIG. 57C, adapter 1810 is secured to insertionmember 1442 using, for example, set screw 2010 (FIG. 57A) or any othersuitable means of connection. Other means of connection include, but arenot limited to, clamps, cams, spring-loaded pins, and/or latches. Theaxes of the handle 1244 and insertion member 2042 are as describedabove. The adapter is configured to fit with a customary handle (such ashandle 1244 shown in FIG. 57E) and a customary insertion member (such asbroach 1442). The alignment and angulation of the post 2072 of adapter1810 relative to the cavity 2002 achieves the dual offset between thehandle and the insertion member detailed above. Thus, depending on whichleg is being operated, a surgeon may connect the respective post 2072 or2074 of the adapter 1810 to the conventional single offset handle. Useof adapter 1810 offsets the axis of the handle 1244 both anteriorly andlaterally from the axis of the insertion member 1442. As described indetail above, this anterior and lateral offset provides a clearance ofthe handle with respect to the patient's gut zone and other musculature.

FIGS. 58A and 59A illustrate alternate adapters 1820 and 1830. Likeadapter 1810, adapters 1820 and 1830 may be used with a conventionalsingle offset handle (such as handle 1244 shown in FIG. 59B) andconventional insertion member (such as broach 1442) for operating on apatient's medullary canal to achieve the dual offset described above.Adapters 1820 and 1830 may include a body 1814 and a recess forreceiving post 1472 of a conventional insertion member 1442.Alternatively, in certain embodiments, adapters 1820 and 1830 mayinclude a protrusion for insertion into the cavity of a post-lessinsertion member (not shown).

In some embodiments, adapters 1820 and 1830 include a single angled post2172 that is configured to connect with a receiving portion of aconventional single offset handle used for operating on a patient'smedullary canal, as shown in FIGS. 58B-C and FIG. 59B.

Adapter 1820 illustrated in FIG. 58A is configured for use whenoperating on a right femur, and adapter 1830 illustrated in FIG. 59B isconfigured for use when operating on a left femur. In use, eitheradapter 1820 or 1830 is secured to insertion member 1442 using, forexample, a set screw as described above or any other suitable means ofconnection. Other means of connection include, but are not limited to,clamps, cams, spring-loaded pins, and/or latches.

Adapters 1820 and 1830 are configured to fit with a customary handle(such as handle 1244 shown in FIGS. 58B-C and FIG. 59B) and a customaryinsertion member (such as broach 1442). The alignment and angulation ofthe post 2172 of adapters 1820 or 1830 relative to the post 1472achieves the dual offset between the handle and the insertion memberdetailed above. Thus, depending on which leg is being operated, asurgeon may connect either adapter 1820 or 1830 to the conventionalsingle offset handle, as illustrated in FIGS. 58B-58C and 59B. Use ofeither adapter 1820 or 1830 offsets the axis of the handle 1244 bothanteriorly and laterally from the axis of the insertion member 1442. Asdescribed in detail above, this anterior and lateral offset provides aclearance of the handle with respect to the patient's gut zone and othermusculature.

In use, the desired embodiment of the instrument is selected and eitherthe left or right femur of the patient is selected for installation of aprosthetic stem component. The instrument is configured to operate onthe selected femur by causing the handle to be offset from the surgicalmember in the direction that includes an X directional component andalso a Y directional component to provide the desired lateral andanterior offset of the handle relative to the shaping member. Theshaping member portion of the instrument, or the instrument, is theninserted into the medullary canal of the selected femur through asurgical incision using an anterior approach. The medullary canal isthen operated on using the instrument. The instrument is then removedand a prosthetic stem component is installed in the medullary canal andthe surgery completed.

While the instruments described herein have been described for use withfemoral intramedullary canal preparation, they may be advantageouslyutilized with any surgical procedure. For example, the instrumentsaccording to various embodiments of the invention may be utilized toprepare a humerus during shoulder surgery, prepare a femoral head forfemoral head resurfacing, or to prepare an acetabulum (e.g., offsettingan acetabular shaping member in a negative X direction and a negative Ydirection for acceptance of an acetabular implant). In such lattercases, as for use in acetabular preparation with a direct anteriorapproach, a distal end of the instrument can generally be configured toextend in the Z direction (towards the head of the patient), and anopposite configuration can be used. For instance, the instrumentconfiguration shown in FIG. 6 for use on a left femur may correspond tothe configuration used for a right acetabulum when accessing theacetabulum from a distal perspective relative to a patient. Conversely,the instrument configuration shown in FIG. 7 for use on a right femurcould correspond to the configuration used for a left acetabulum whenaccessing the acetabulum from a distal perspective relative to apatient. In yet other examples, the shaping member may be provided as areamer, in which cases the instrument body may contain a universaljoint, coupling, or other mechanism which can be attached to a drillmember for transferring a torque to said reamer. In yet even otherexamples, the shaping member may be configured as an insertion memberadapted to at least temporarily mate with a prosthetic implant such as afemoral stem or acetabular cup and guide and place it within a surgicalsite.

In use, the desired embodiment of the instrument is selected and eitherthe left or right hip of the patient is selected for installation of aprosthetic stem component. The instrument is configured to operate onfemur of the selected leg by causing the handle to be offset from theshaping member in the direction that includes a lateral and an anteriordirectional component to provide the desired lateral and anterior offsetof the handle relative to the shaping member. The shaping member portionof the instrument is then inserted into the intramedullary canal of theselected leg through a surgical incision using an anterior approach. Theintramedullary canal is operated on using the instrument. The instrumentis then removed and a prosthetic stem component is installed in theintramedullary canal, an acetabular cup can be installed in theacetabulum of the patient, and the surgery completed.

The embodiments disclosed above were chosen and described in order bestto explain the principles of the invention and its practical applicationthereby to enable others skilled in the art best to make and utilize theinvention and various embodiments and with various modifications as aresuited to the particular manufacture or use contemplated. As variousmodifications could be made in the constructions and methods hereindescribed and illustrated without departing from the scope of theinvention, it is intended that all matter contained in the foregoingdescription or appended claims, or shown in the accompanying drawingsshall be interpreted as illustrative rather than limiting. Thus, breadthand scope of the present invention should not be limited by any of theabove-described embodiments, but should be defined only in accordancewith the following claims appended hereto and their equivalents.

What is claimed is:
 1. An instrument for shaping a medullary canal ofboth a patient's left leg and right leg, comprising: (a) a handle thatincludes a handle longitudinal axis; (b) a shaping member including:structure configured to shape bone; a shaping member longitudinal axis,and a connecting structure that includes an interpositional cooperationstructure; (c) an offset member that physically connects the handle tothe shaping member, the offset member extending in an offset directionthat includes a first directional component in a first directionorthogonal to the longitudinal axis of the shaping member, and a seconddirectional component in the direction of the shaping memberlongitudinal axis; (d) the offset member including: (i) a first openingadapted to receive the shaping member connecting structure, the firstopening configured to receive the shaping member connecting structure ina manner whereby the shaping member longitudinal axis is substantiallyparallel to the handle longitudinal axis; (ii) a second opening adaptedto receive the shaping member connecting structure, the second openingconfigured to receive the shaping member connecting structure in amanner whereby the shaping member longitudinal axis is substantiallyparallel to the handle longitudinal axis; and (e) a retention device ormember comprising an actuator and at last one interpositional structure,the retention device or member configured to interpose the at least oneinterpositional structure relative to the interpositional cooperationstructure of the shaping member connecting structure when the actuatoris actuated.
 2. The instrument of claim 1, wherein the shaping membercomprises a reference plane and the first and second openings areconfigured to receive the shaping member connecting structure in amanner such that the first direction orthogonal to the longitudinal axisof the shaping member bisects the angle formed by the shaping memberreference plane when the shaping member is connected to the firstopening and the shaping member reference plane when the shaping memberis connected to the second opening.
 3. The instrument of claim 1,wherein the shaping member comprises a reference plane and the first andsecond openings are configured to receive the shaping member connectingstructure in a manner such that when the shaping member is connected tothe first opening, the shaping member reference plane is substantiallyorthogonal to the shaping member reference plane when the shaping memberis connected to the second opening.
 4. The instrument of claim 1,wherein the shaping member is a broach.
 5. The instrument of claim 1,wherein the shaping member is a femoral shaping member for preparationof a central femoral cavity for receiving a stem of a femoral componentof a prosthetic hip.
 6. The instrument of claim 1, further comprising astrike plate with a first beveled surface that corresponds to the firstopening on the offset member and a second beveled surface thatcorresponds to the second opening on the offset member.
 7. Theinstrument of claim 1, wherein the offset member extends in at least twooffset directions.
 8. The instrument of claim 1, wherein the offsetdirection includes a third directional component that is orthogonal tothe first directional component, the second directional component, andthe longitudinal axis of the shaping member.
 9. The instrument of claim1, wherein the offset member includes a first abutment surface and asecond abutment surface, the first abutment surface corresponding to thefirst opening and configured to abut a proximal surface of the shapingmember, the second abutment surface corresponding to the second openingand configured to abut a proximal surface of the shaping member.
 10. Theinstrument of claim 1, wherein the actuator of the retention device ormember includes an over-center linkage configured to lock theinterpositional structure in place when interposed with theinterpositional cooperation structure of the shaping member connectingstructure, and wherein the interpositional structure comprises at leastone pawl.
 11. The instrument of claim 1, wherein the actuator of theretention device or member includes a wedge, the interpositionalstructure includes at least one claw, and the wedge is configured tourge the at least one claw into interposed position with theinterpositional cooperation structure of the shaping member connectingstructure.
 12. An instrument for operating on a medullary canal forinstallation of a prosthetic stem component in a patient, comprising: ahandle including an elongated shaft extending approximately in anegative z-direction; a first offset capable of extending in a firstdirection that includes an x-directional component or a negativex-directional component; a second offset extending in a second directionthat includes a negative y-directional component; the handle connectedto either the first or second offset; an insertion member extending fromeither the first offset or the second offset in an insertion memberdirection that includes a negative z-directional component; wherein thenegative y-directional component and negative z-directional componentsare orthogonal to each other and orthogonal to the x-directionalcomponent and the negative x-directional component, and wherein thehandle and the insertion member are positioned with respect to oneanother in a non-planar relationship.
 13. The instrument of claim 12,wherein one of the offsets is connected to the handle via a pivotcapable of rotating relative to the handle such that one of the offsetsextends in approximately an x-direction or a negative x-direction inorder to configure the instrument for use with a right leg or a left legof the patient.
 14. The instrument of claim 12, wherein the handle isconfigured to connect to the second offset on either a first side of thehandle that faces the x direction or a second side of the handle thatfaces the negative x direction in order to form the first offset. 15.The instrument of claim 12, wherein the insertion member furthercomprises cutting elements.
 16. An instrument for operating on amedullary canal for installation of a prosthetic stem component in apatient, comprising: a handle including an elongated shaft extending inan approximately negative z-direction; an offset connected to thehandle, the offset extending in a first direction that includes anegative y-directional component and capable of extending in a seconddirection that includes an x-directional component or a negativex-directional component; a shaping member extending from the offset in ashaping member direction that includes a negative z-directionalcomponent, wherein the negative y-directional component and negativez-directional components are orthogonal to each other and orthogonal tothe x-directional component and the negative x-directional component,wherein the handle and the shaping member are positioned with respect toone another in a non-coplanar relationship, and wherein the shapingmember further comprises cutting elements.
 17. The instrument of claim16, wherein the offset is connected to the handle via a pivot, and thehandle and pivot are capable of rotating relative to each other suchthat the offset extends in a direction that includes an x-directionalcomponent or a negative x-directional component in order to configurethe instrument for use with a right leg or a left leg of the patient.